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Clinical Trials/NCT05709132
NCT05709132
Recruiting
Not Applicable

Implementation and Preliminary Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program for Adolescent and Transitioning Heart Function Patients

The Hospital for Sick Children1 site in 1 country55 target enrollmentJanuary 1, 2024
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
The Hospital for Sick Children
Enrollment
55
Locations
1
Primary Endpoint
Acceptability (Mentees)
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

The iPeer2Peer (iP2P) program is an online peer support mentorship program that provides modelling and reinforcement by trained young adult peer mentors to adolescent mentees with the same condition. A quasi-experimental single-arm pre-post study design will be employed across three sites. We will recruit 40 mentees (12-17 years of age) and 12-15 mentors (18-30 years of age) who will undergo training in mentoring and the use of eHealth technology. Mentor-mentee pairings will connect over 15 weeks through video calls and text messaging to provide peer support and encourage disease self-management skills. Data will be collected using standardized instruments and interviews across three time points.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
April 13, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samantha Anthony

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • significant cognitive impairments as assessed by a qualified healthcare provider,
  • a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their heart failure care regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
  • participating in other peer support or self-management interventions.

Outcomes

Primary Outcomes

Acceptability (Mentees)

Time Frame: 15 weeks after baseline/immediately after the intervention

Whether the innovation is agreeable, palatable or satisfactory

Feasibility (Mentees)

Time Frame: Baseline to 12 weeks post-program completion

The extent to which an innovation can be used or carried out successfully in a given setting

Feasibility (Mentors)

Time Frame: Baseline to study completion, an average of 1 year

The extent to which an innovation can be used or carried out successfully in a given setting

Appropriateness (Mentees)

Time Frame: Baseline to 12 weeks post-program completion

The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem

Level of engagement (Mentees)

Time Frame: 15 weeks after baseline/immediately after the intervention

Appropriateness (Mentors)

Time Frame: Baseline to study completion, an average of 1 year

The perceived fit, relevance or compatibility of the innovation for a practice setting; and/or its perceived fit to address an issue or problem

Level of engagement (Mentors)

Time Frame: Study completion, an average of 1 year

Acceptability (Mentors)

Time Frame: Study completion, an average of 1 year

Whether the innovation is agreeable, palatable or satisfactory

Adoption (Mentees)

Time Frame: Baseline to 12 weeks post-program completion

The intention, initial decision or action to try or use an innovation

Adoption (Mentors)

Time Frame: Baseline to study completion, an average of 1 year

The intention, initial decision or action to try or use an innovation

Secondary Outcomes

  • Disease self-management skills (Mentees)(Baseline to 12 weeks post-program completion)
  • Emotional distress (Mentees)(Baseline to 12 weeks post-program completion)
  • Perceived social role satisfaction (Mentors)(Baseline to study completion, an average of 1 year)
  • Self-efficacy (Mentors)(Baseline to study completion, an average of 1 year)
  • Assessment of mentor quality (Mentees)(15 weeks after baseline/immediately after the intervention)
  • Physical and emotional symptoms (Mentors)(Baseline to study completion, an average of 1 year)
  • Adherence (Mentees)(Baseline to 12 weeks post-program completion)
  • Perceived social support (Mentees)(Baseline to 12 weeks post-program completion)
  • Resiliency (Mentees)(Baseline to 12 weeks post-program completion)
  • Quality of life (Mentees)(Baseline to 12 weeks post-program completion)

Study Sites (1)

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